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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories
510(k) Number K951905
Device Name SCISSORS, UNIVERSAL, LAPAROSCOPIC W/MONOPOLAR CAUTERY REUSABLE
Applicant
H.S. Intl. Co., Inc.
5040 Commercial Cir., Unit A
Concord,  CA  94520
Applicant Contact HENRY SHAPIRO
Correspondent
H.S. Intl. Co., Inc.
5040 Commercial Cir., Unit A
Concord,  CA  94520
Correspondent Contact HENRY SHAPIRO
Regulation Number878.4400
Classification Product Code
GEI  
Date Received04/24/1995
Decision Date 07/11/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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